The Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Baxdela (delafloxacin; Melinta Therapeutics) for the treatment of community acquired bacterial pneumonia (CABP) in adult patients.
The approval was based on results from the phase 3 DEFINE-CABP trial (N=860) that compared the efficacy and safety of Baxdela to moxifloxacin for the treatment of CABP. Patients were randomized to receive Baxdela 300mg intravenously (IV) every 12 hours (for ≥6 doses) or moxifloxacin 400mg IV every 24 hours (for ≥3 doses) with potential to switch to the oral formulation. The primary endpoint was early clinical response (ECR) defined as improvement in ≥2 of the following symptoms: chest pain, frequency or severity of cough, the amount and quality of productive sputum, and difficulty breathing, and no worsening in the other symptoms in the intent-to-treat population.
Results showed IV-to-oral Baxdela to be statistically non-inferior to IV-to-oral moxifloxacin for early clinical response at 96 hours (± 24 hours) after initiating therapy (88.9% vs 89.0% ECR, respectively). Additionally, Baxdela met the investigator’s assessment of success at the test of cure visit (secondary end point), defined as 5-10 days after the last dose, of statistical non-inferiority compared with moxifloxacin (90.5% vs 89.7%, respectively). Further analysis between both treatment arms also demonstrated similar rates of eradicated key respiratory pathogens.
The overall safety profile of Baxdela was comparable to moxifloxacin with the most common treatment-emergent adverse events being diarrhea and increased transaminase levels.
Baxdela, a fluoroquinolone antibiotic, is already indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of gram-positive and gram-negative organisms.
The product is available as 450mg strength tablets in 20-count bottles and as 300mg strength lyophilized powder in single-dose vials in 10-count cartons. The 450mg tablet is bioequivalent to, and interchangeable with, the 300mg IV dose.
For more information visit baxdela.com.